Probiotic Formula and Infant Growth

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01476397
• Collaborator: (none)
• Locations: 8
• Arms: 2
• Duration (Months): 22

Study Details

Study Description

Brief Summary

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Control infant formula; Other: Test infant formula	N/A

Study Design

• Study Type: Interventional
• Official Title: ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control infant formula partially hydrolyzed whey infant formula	Other: Control infant formula; partially hydrolyzed whey infant formula consumed ad libitum throughout study
Experimental: test infant formula partially hydrolyzed whey infant formula with probiotic	Other: Test infant formula; partially hydrolyzed whey formula with probiotic

Outcome Measures

Primary Outcome Measures

1. growth [4 months]

   weight gain assessed monthly

Secondary Outcome Measures

1. other growth [4 months]

   Length, head circumference will be measured at monthly visits

2. adverse events [4 months]

   all adverse events will be documented throughout the study

3. stool characteristics [throughout study]

   stool frequency, color, consistency

4. spit-up [throughout study]

   frequency of spit-up as reported by caregivers

5. vomit [throughout study]

   frequency of vomitting as reported by caregivers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Days to 17 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy newborn infant

• Full-term

• Birth weight > 2500 and < 4500 g

• 14±3 days of age on enrollment

• Exclusively formula-fed, singleton birth

• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Known or suspected cow-milk allergy

• Congenital illness or malformation that may affect infant feeding and/or growth

• Significant prenatal and/or postnatal disease

• Any readmission to hospital prior to enrollment

• Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements

• Has received intravenous antibiotic therapy or oral probiotic in the last 7 days

• Currently participating in another clinical study

• Cannot be expected to comply with treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Scottsdale Pediatric Associates	Scottsdale	Arizona	United States	85258
2	Pediatrics & Adolescent Medicine	Marietta	Georgia	United States	30189
3	Kentucky Pediatric Adult Research	Bardstown	Kentucky	United States	40004
4	PMG Research of Winston-Salem	Winston-Salem	North Carolina	United States	27103
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425
6	PMG Research of Bristol	Bristol	Tennessee	United States	37620
7	Pediatric Healthcare of Northwest Houston	Tomball	Texas	United States	77375
8	Advanced Pediatrics	Vienna	Virginia	United States	22180

Sponsors and Collaborators

• Nestlé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT01476397
• Other Study ID Numbers: 10.01.US.INF
• First Posted: Nov 22, 2011
• Last Update Posted: Nov 4, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Nestlé: full-term; formula-fed infants

Study Results

No Results Posted as of Nov 4, 2014